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INmune Bio Inc. Announces Second Quarter 2026 Results and Highlights Regulatory, Manufacturing and Clinical Progress
INmune Bio Inc. Announces Second Quarter 2026 Results and Highlights Regulatory, Manufacturing and Clinical
About this update from Inmune Bio Inc.
BOCA RATON, Fla. , Aug. 06, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced its financial results for the quarter ended June 30, 2026 and provided a business update. “The second quarter and subsequent weeks were defined by execution across both of our late-stage platforms,” said David Moss , Chief Executive Officer of INmune Bio . “For Ebstrocel™, we secured MHRA alignment, PIP approval and commercial-ready manufacturing, materially reducing regulatory and operational risk ahead of our planned UK MAA submission. For XPro™, FDA Fast Track designation and statistically significant MRI findings strengthened the clinical and regulatory foundation for a registrational Phase 2b/3 program in early Alzheimer’s disease that we believe establishes XPro™ as a first-in-class, late-stage neuroimmunology program in CNS disease. Looking ahead, our core priority is clear: driving Ebstrocel efficiently through regulatory filing and approval to bring this critical therapy to patients in need while delivering long-term value for our shareholders.” Second Quarter and Recent Corporate Highlights CORDStrom™ Platform (Ebstrocel for RDEB): Completed a key commercial manufacturing milestone by successfully processing the first commercial-ready umbilical cord tissues at the Cell and Gene Therapy Catapult Manufacturing Innovation Centre in Stevenage, UK . The transferred process is designed to meet MHRA, EMA and FDA standards and supports planned Phase 3 confirmatory development, global regulatory submissions and future commercial supply. Received formal MHRA written alignment across the CMC, non-clinical and clinical elements of the planned UK MAA, providing a clear regulatory path toward a Conditional Marketing Authorization application for Ebstrocel™ in RDEB. Obtained MHRA approval of the Ebstrocel™ Pediatric Investigation Plan in less than three months, preserving the Company’s planned 2026 UK MAA timetable and incorporating the agency’s feedback into the planned open-label Phase 3 confirmatory trial. Completed preparations for the Phase 3 trial of Ebstrocel in RDEB remaining on track for first patient treatment in Q4 2026. Advanced the CORDStrom™ platform patent application into the U.S . national phase following a favorable international Written Opinion. If granted, the patent family is expected to provide broad platform protection, including composition-of-matter and method-of-treatment claims, extending into at least 2045. Expanded the Company’s agreement with Anthony Nolan Cord Blood Bank , securing long-term access to high-quality umbilical cord tissue to support scalable global development and commercialization of the CORDStrom™ platform. Established a Scientific Advisory Board comprising internationally recognized leaders in MSC biology, clinical translation, manufacturing, potency assessment and rare pediatric skin disease. Chaired by Professor Mark Lowdell , the working SAB will support Ebstrocel’s late-stage regulatory and clinical development, including Phase 3 design, biomarkers, manufacturing consistency and product-release criteria, while helping prioritize additional indications for the CORDStrom platform. The SAB adds substantial independent expertise as the Company advances Ebstrocel toward regulatory submissions and expands CORDStrom into additional disease-specific cell therapies. XPro1595 Platform Highlights (XPro™): Reported a statistically significant treatment effect on a white matter myelin MRI biomarker in the Phase 2 MINDFuL trial. XPro™ demonstrated an effect in the full modified intent-to-treat population (p=0.0028; Cohen’s d=0.46; n=200), with a larger effect in the biomarker-enriched population (p=0.0098; d=0.59; n=100), supporting the precision-medicine strategy for the planned registrational program. Published the Phase 2 MINDFuL results in NPJ Dementia . In the pre-specified, protocol-defined Alzheimer’s Disease with inflammation (ADi) subgroup, XPro™ showed directionally consistent benefit across cognitive, global, functional, behavioral and biomarker endpoints over 24 weeks, with zero ARIA-E and zero ARIA-H observed. Presented expanded Phase 2 imaging analyses at the Alzheimer’s Association International Conference showing concordant treatment-related effects across independent white matter and cortical gray matter measures at Week 24, strengthening evidence of early biologic activity and tissue-level target engagement. Received FDA Fast Track designation for XPro™ (pegipanermin) for early Alzheimer’s disease, encompassing mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia, enabling more frequent FDA interactions and potential eligibility for expedited review mechanisms. Published a Department of Defense-funded , peer-reviewed Journal of Neurotrauma study showing that XPro1595 prevented the injury-induced rise in amyloid pathology and improved early cognitive and pain-related outcomes in a preclinical model linking traumatic brain injury to Alzheimer’s disease. Presented AACR 2026 preclinical data showing that INB03 (XPro1595 for oncology) enhanced the activity of HER2-targeted tyrosine kinase inhibitors and reduced metastatic spread to the brain, lungs and liver in HER2-positive breast cancer models. Corporate: Received an approximately US$4.2 million research and development tax rebate from Australia during July 2026 , providing non-dilutive capital to support ongoing development activities. Announced it has been named a founding member of the American Biotech Innovation Alliance (ABIA). The newly launched national coalition brings together biotechnology leaders with the shared objective of defining a national strategy to sustain and extend U.S . leadership in biotech innovation. Upcoming Events and Milestones: Submit the Ebstrocel™ Marketing Authorization Application to the UK MHRA by the end of Q3 or early Q4 2026, followed by a planned European Union submission to the EMA in Q1 2027. Ebstrocel™ Biologics License Application (BLA) submission to the FDA expected in Q1 2027. Submit the registrational Phase 2b/3 protocol for XPro™ in early Alzheimer’s disease to the FDA in [Q4 2026]. Submit for publication the Phase 2 MINDFuL imaging analyses, including the white matter and cortical gray matter findings presented at AAIC 2026. Financial Results for the Second Quarter Ended June 30, 2026 : Net loss attributable to common stockholders for the quarter ended June 30, 2026 was approximately $1.3 million , compared to approximately $24.5 million for the quarter ended June 30, 2025 . The prior-year period included a $16.5 million impairment charge related to acquired in-process research and development intangible assets. Research and development expenses totaled approximately $(0.8 million) for the quarter ended June 30, 2026 , compared to approximately $5.8 million for the quarter ended June 30, 2025 . The research and development benefit during the 2026 period was primarily due to the recognition of additional Australian research and development tax rebate. General and administrative expenses were approximately $2.3 million for each of the quarters ended June 30, 2026 and June 30, 2025 . As of June 30, 2026 , the Company had cash and cash equivalents of approximately $18.4 million . As of August 6, 2026 , the Company had approximately 27.8 million common shares outstanding. Earnings Call Information To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Second Quarter Conference Call when reaching the operator. Date: August 6 th , 2026 Time: 4:30 PM Eastern Time Participant Dial -in: 1-800-717-1738 Participant Dial -in (international): +1-646-307-1865 Conference ID: INMUNE A live audio webcast of the call can be accessed by clicking here or using this link: https://viavid.webcasts.com/starthere.jsp?ei=1769234&tp_key=7c277bcdb8 A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through September 21st, 2026 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN 1166817. About INmune Bio Inc. INmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. Moving beyond early-stage exploration, the Company’s clinical-development strategy centers on advanced precision medicine, matching drug mechanisms directly to patient biology to optimize clinical outcomes. INmune Bio is actively advancing two late-stage product platforms toward registrational milestones: CORDStrom™: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell platform engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts in RDEB, the platform is transitioning to regulatory filing phases, with an MAA planned for the UK MHRA in 2026 and EU EMA in 2027, alongside a planned U.S. Biologics License Application (BLA) submission. XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform that selectively neutralizes soluble TNF (sTNF) to eliminate neuroinflammation without compromising protective immune function. Backed by recently granted FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, XPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease. To learn more about INmune Bio’s pipeline and its approach to harnessing the innate immune system, please visit www.inmunebio.com. Forward Looking Statements The Company’s product candidates are in clinical development and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including the timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDStrom™, XPro1595™ (XPro™, pegipanermin), and INKmune™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the U.S. Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release. INmune Bio Contacts: David Moss Chief Executive Officer (561) 710-0512 [email protected] Daniel Carlson Head of Investor Relations (415) 509-4590 [email protected] The following tables summarize our results of operations for the periods indicated: INMUNE BIO INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) (Unaudited) June 30 , 2026 December 31 , 2025 ASSETS CURRENT ASSETS Cash and cash equivalents $ 18,411 $ 24,751 Research and development tax credit receivable 4,413 4,284 Other tax receivable 354 257 Prepaid expenses and other current assets 621 595 TOTAL CURRENT ASSETS 23,799 29,887 Equipment, net 1,262 955 Operating lease – right of use asset 1,247 914 Other assets 537 595 TOTAL ASSETS $ 26,845 $ 32,351 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES Accounts payable and accrued liabilities $ 5,053 $ 7,768 Accounts payable and accrued liabilities – related parties 25 25 Operating lease, current liabilities 812 623 TOTAL CURRENT LIABILITIES 5,890 8,416 Long-term operating lease liability 593 411 TOTAL LIABILITIES 6,483 8,827 COMMITMENTS AND CONTINGENCIES STOCKHOLDERS’ EQUITY Preferred stock, $0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding - - Common stock, $0.001 par value, 200,000,000 shares authorized, 27,653,789 and 26,585,258 shares issued and outstanding, respectively 28 27 Additional paid-in capital 237,688 233,271 Subscription receivable (814 ) - Accumulated other comprehensive loss (823 ) (737 ) Accumulated deficit (215,717 ) (209,037 ) TOTAL STOCKHOLDERS’ EQUITY 20,362 23,524 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 26,845 $ 32,351 INMUNE BIO INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share amounts) (Unaudited) For the Three Months Ended June 30 , For the Six Months Ended June 30 , 2026 2025 2026 2025 REVENUE $ - $ - $ - $ 50 OPERATING EXPENSES General and administrative 2,279 2,253 4,450 4,569 Research and development (803 ) 5,804 2,838 13,443 Impairment of acquired in-process research and development intangible assets - 16,514 - 16,514 Total operating expenses 1,476 24,571 7,288 34,526 LOSS FROM OPERATIONS (1,476 ) (24,571 ) (7,288 ) (34,476 ) OTHER INCOME, NET 203 113 608 279 NET LOSS $ (1,273 ) $ (24,458 ) $ (6,680 ) $ (34,197 ) Net loss per common share – basic and diluted $ (0.05 ) $ (1.05 ) $ (0.25 ) $ (1.49 ) Weighted average common shares outstanding – basic and diluted 26,718,507 23,298,455 26,652,250 22,899,539 COMPREHENSIVE LOSS Net loss $ (1,273 ) $ (24,458 ) $ (6,680 ) $ (34,197 ) Other comprehensive loss – foreign currency translation (96 ) (153 ) (86 ) (188 ) Total comprehensive loss $ (1,369 ) $ (24,611 ) $ (6,766 ) $ (34,385 ) INMUNE BIO INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) (Unaudited) For the Six Months Ended June 30 , 2026 2025 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ (6,680 ) $ (34,197 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 2,855 3,610 Gain on settlement of accounts payable (91 ) - Depreciation expense 118 - Impairment of acquired research and development intangible assets - 16,514 Changes in operating assets and liabilities: Research and development tax credit receivable (129 ) (424 ) Other tax receivable (97 ) (322 ) Prepaid expenses (26 ) (174 ) Other assets 58 (491 ) Accounts payable and accrued liabilities (2,624 ) 1,132 Accounts payable and accrued liabilities – related parties - 159 Deferred liabilities - (6 ) Operating lease liabilities 38 - Net cash used in operating activities (6,578 ) (14,199 ) CASH FLOWS FROM INVESTING ACTIVITIES: Purchase of equipment (430 ) (706 ) Net cash used in investing activities (430 ) (706 ) CASH FLOWS FROM FINANCING ACTIVITIES: Sale of common stock for cash 584 27,544 Exercise of warrants for cash 130 1 Exercise of stock options for cash 35 - Net cash provided by financing activities 749 27,545 Impact on cash from foreign currency translation (81 ) (188 ) NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS (6,340 ) 12,452 CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 24,751 20,922 CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 18,411 $ 33,374 SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: Cash paid for income taxes $ - $ - Cash paid for interest $ - $ - SUPPLEMENTAL NONCASH INVESTING AND FINANCING ACTIVITIES Right of use assets obtained in exchange for lease obligations $ 587 $ - Source: INmune Bio, Inc. 2026 GlobeNewswire, Inc., source Press Releases